Assessment of Tacrolimus Impact on Glycemic Control in Hemodialysis Patients Pre-Renal Transplantation

The primary objective of this study is to **determine the proportion** of patients undergoing **hemodialysis** who experience a change in their glycemic profile when treated with **tacrolimus**. This is clinically relevant as it addresses the potential impact of tacrolimus on carbohydrate metabolism, which is crucial for managing patients awaiting renal transplantation. Understanding these effects can guide therapeutic decisions and improve patient outcomes in this population.

The clinical trial involves **hemodialysis** patients, with the primary objective of determining the proportion of these patients who experience changes in their glycemic profile when administered Tacrolimus. The study population includes both male and female participants aged 18 years and older, who are eligible for a kidney transplant at Nantes University Hospital. Participants are required to be undergoing hemodialysis at one of the participating centers and must be capable of understanding the proposed protocol, having provided free and informed consent. Additionally, participants must have social security coverage. The sponsor has not provided information regarding the total number of participants. The trial does not specifically target a vulnerable population, and no particular lifestyle considerations such as diet or physical activity are highlighted in the selection criteria.

The clinical trial is designed to evaluate the effect of **tacrolimus** on carbohydrate metabolism in patients undergoing **hemodialysis** prior to renal transplantation. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is set to run from March 8, 2019, to June 8, 2025, with the primary objective of determining the proportion of hemodialysis patients who experience a change in their glycemic profile after treatment with tacrolimus.

Participants will be involved in the study for a maximum of 14 days, during which they will receive a daily oral dose of tacrolimus at 0.1 mg/kg. The study includes several key visits: an initial screening visit to confirm eligibility, follow-up visits to monitor changes in glycemic profiles, and an end-of-study visit to assess the primary endpoint. The primary endpoint is a significant change in the glycemic profile between Day 0 (before treatment) and Day 14 (after treatment).

Inclusion criteria for the study require participants to be 18 years or older, eligible for a kidney transplant at Nantes University Hospital, and currently undergoing hemodialysis at one of the participating centers. Participants must also be able to understand the protocol and provide informed consent, as well as have social security coverage. There are no specified exclusion criteria. Conditions that may lead to early termination from the study include adverse reactions to the medication or withdrawal of consent by the participant.

The clinical trial involves the administration of **Tacrolimus**, a chemical compound used primarily for **reject prevention** in organ transplantation. Tacrolimus is provided in an oral pharmaceutical form, identified by the code PHF00170MIG. The medication is administered orally at a dosage of 0.1 mg/kg per day. The maximum treatment period for participants is 14 days. The active substance, Tacrolimus, is also known by the synonym Tacrolimus Anhydrous and is classified under the ATC code L04AD02. The trial aims to evaluate the effect of Tacrolimus on carbohydrate metabolism in pre-renal transplantation dialysis patients.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of Tacrolimus to assess its impact on the glycemic profile of hemodialysis patients. Participant compliance with the dosing schedule is monitored to ensure adherence to the treatment protocol. The trial is authorized and conducted in accordance with regulatory standards, with the primary objective of determining the proportion of patients experiencing changes in their glycemic profile while on Tacrolimus therapy.

The efficacy of the clinical trial evaluating the effect of **tacrolimus** on carbohydrate metabolism in pre-renal transplantation dialysis patients will be assessed primarily through the measurement of changes in the glycemic profile. The primary endpoint is defined as a significant change in the glycemic profile between Day 0 (before the start of treatment) and Day 14 (after 14 days of tacrolimus treatment). This assessment will involve comparing glycemic levels at these two timepoints to determine the impact of tacrolimus on the patients' carbohydrate metabolism.